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NEW YORK ─ Advanced Biological Laboratories said on Monday that it has received CE-IVD marking for its UltraGene Combo2Screen SARS-CoV-2 qPCR assay, enabling its use in the European Union and other countries that accept the designation.

The Luxembourg-based firm said the qPCR detection kit has been validated with SARS-CoV-2 RNA extracted from nasopharyngeal swabs and saliva.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.